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Diabetes Mellitus, Type 2Phase 2/3NCT00821977

Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes

A Phase 2/3 study testing Vildagliptin in people with Diabetes Mellitus, Type 2, run by Novartis at 176 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Vildagliptin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
338 participants
Where
176 sitesin 8 countries
Study dates
Nov 2008to Oct 2010
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients at least 18 years of age at Visit 1
  • Drug naïve patients with T2DM diagnosed at least 2 months prior to Visit 1
  • HbA1c ≥ 7.0 % and ≤ 10.0% at Visit 1
  • Body Mass Index (BMI) in the range of 22-45 kg/m2 at Visit 1

Who cannot join

  • Pregnant or lactating female
  • FPG ≥ 270 mg/dL (≥15 mmol/L)
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

176 sites in 8 countries.

176 sites in 8 countries

United States141 sites

  • ACRC Trials

    Addison, Texas, 75093

  • The Endocrine Group, LLP

    Albany, New York, 12206

  • JMG CIinical Research

    Alton, Illinois, 62002

  • Blair Medical Associates Inc

    Altoona, Pennsylvania, 16602

  • Hartwell Research Group, LLC

    Anderson, South Carolina, 29621

  • Sall Research Medical Center

    Artesia, California, 90704

  • Southern Clinical Research

    Augusta, Georgia, 30904

  • Fox Valley Clinical Research

    Aurora, Illinois, 60504

  • AM Diabetes and Endocrinology Center

    Bartlett, Tennessee, 38133

  • Dolby Research, LLC

    Baton Rouge, Louisiana, 70809

  • Discover Research Inc.

    Beaumont, Texas, 77701

  • MW Clinical Research

    Beaumont, Texas, 77701

  • Tri-State Medical Group

    Beaver, Pennsylvania, 15009

  • Madrona Medical Group - Clinical Research Dept.

    Bellingham, Washington, 98226

  • Belzoni Clinical Research

    Belzoni, Mississippi, 39038

  • Progressive Clinical Research

    Bountiful, Utah, 84010

  • Tri-Cities Medical Research

    Bristol, Tennessee, 37620

  • Discover Research

    Bryan, Texas, 77802

  • Associated Pharmaceutical Research

    Buena Park, California, 90620

  • Providence Research

    Burbank, California, 91505

  • Burbank - Lovelace Scientific Resources, Inc.

    Burbank, California, 91506

  • Cornerstone Medical Center

    Burlington, North Carolina, 27215

  • Kernodle Clinic, Inc.

    Burlington, North Carolina, 27215

  • Low Country Internal Medicine

    Charleston, South Carolina, 29406

  • Pharmacorp Clinical Trials, INC

    Charleston, South Carolina, 29412

  • Neem Research Group of Charlotte

    Charlotte, North Carolina, 28262

  • Michigan Hypertension Center

    Chelsea, Michigan, 48118

  • Woodlake Research

    Chesterfield, Missouri, 63017

  • Midwest Pharmaceutical Research Inc.

    City of Saint Peters, Missouri, 63376

  • Midwest Pharmaceutical Research, Inc.

    City of Saint Peters, Missouri, 63376

  • The Family Healthcare Center

    Clinton, South Carolina, 29325

  • Colorado Springs Health Partners, Pc

    Colorado Springs, Colorado, 80907

  • Express Care Clinical Research

    Colorado Springs, Colorado, 80909

  • Columbia Clinical Research

    Columbia, South Carolina, 29201

  • Rockdale Medical Research

    Conyers, Georgia, 30094

  • Clinical Therapeutics Corp

    Coral Gables, Florida, 33134

  • Bruce Samuels LLC

    Covington, Louisiana, 70433

  • New England Center for Clinical Research

    Cranston, Rhode Island, 02920

  • Z&Z Medical Associates/Internal Medicine Clinical Research

    Dallas, Texas, 75235

  • Cherry Creek Family Practice

    Denver, Colorado, 80206

  • Western Sky Medical Research

    El Paso, Texas, 79902

  • North Georgia Medical Research Institute

    Ellijay, Georgia, 30540

  • Endwell Family Physician

    Endwell, New York, 13760

  • Lillestol Research, LLC

    Fargo, North Dakota, 58103

  • Fleetwood Medical Associates

    Fleetwood, Pennsylvania, 19522

  • Genesys Integrated Group Practice, PC

    Flint, Michigan, 48532

  • Study site

    Fort Lauderdale, Florida, 33308

  • Med Plus South - Strand Family Practice

    Garden City, South Carolina, 29576

  • Horizon Clinical Research Associates, PLLC

    Gilbert, Arizona, 85206

  • Bland Clinic, PA

    Greensboro, North Carolina, 27401

  • Triad Clinical Trials, LLC

    Greensboro, North Carolina, 27408

  • DeGarmo Institute of Medical Research

    Greer, South Carolina, 29651

  • Gulfside Clinical Research

    Gulfport, Mississippi, 39501

  • Desert Endocrinology Clinical Research Center

    Henderson, Nevada, 89052

  • HCA Research

    Houston, Texas, 77025

  • Texas Center for Drug Development, P.A.

    Houston, Texas, 77081

  • American Health Network

    Indianapolis, Indiana, 46254

  • Leading Edge Research, PA

    Irving, Texas, 75039

  • Borgess Heart Institute-Borgess Research Institute

    Kalamazoo, Michigan, 49048

  • Truman Medical Center & Univ Physician Associates

    Kansas City, Missouri, 64108

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Gulf Coast Research, LLC

    Lafayette, Louisiana, 70508

  • R/D Clinical Research, Inc.

    Lake Jackson, Texas, 77566

  • Associates Research, Inc

    Lansing, Kansas, 66043

  • Clinical Research Center of NV

    Las Vegas, Nevada, 89104

  • Palm Medical Research Center

    Las Vegas, Nevada, 89148

  • Family Medical Associates

    Levittown, Pennsylvania, 19056

  • Physician Research Collaboration

    Lincoln, Nebraska, 68516

  • Fallbrook Family Health Center

    Lincoln, Nebraska, 68521

  • Medical Investigations, Inc.

    Little Rock, Arkansas, 72205

  • Metro Clinical Research

    Littleton, Colorado, 80120

  • Frederick C. Smith Clinic R & R Research

    Marion, Ohio, 43302

  • Mercy Family Medicine

    Mason City, Iowa, 50401

  • South Texas Institutes of Health

    McAllen, Texas, 78501

  • Vista Medical Research, Inc

    Mesa, Arizona, 85206

  • Clinical Research Advantage

    Mesa, Arizona, 85213

  • Crescent City Clinical Research Center

    Metairie, Louisiana, 70006

  • South Florida Clinical Research Center

    Miramar, Florida, 33023

  • Joslin Diabetes Center

    Nashua, New Hampshire, 03063

  • Hill Country Medical Associates

    New Braunfels, Texas, 78130

  • North Shore Diabetes and Endocrine Associates

    New Hyde Park, New York, 11042

  • Mezitis Education & Research Institute

    New York, New York, 10024

  • Central Sooner Research

    Norman, Oklahoma, 73069

  • Lion Research

    Norman, Oklahoma, 73069

  • North Hills Family Practice

    North Richland Hills, Texas, 76180

  • Complete Family Care

    Northglenn, Colorado, 80234

  • Northport VA Medical Center

    Northport, Virginia, 11768

  • Lucita M. Cruz, M.D., Inc.

    Norwalk, California, 90650

  • Naidu Clinic

    Odessa, Texas, 79761

  • Integris Physicians Services Clinical Research

    Oklahoma City, Oklahoma, 73112

  • Memorial Clinical Research

    Oklahoma City, Oklahoma, 73134

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • Heartland Clinical Research, Inc.

    Omaha, Nebraska, 68134

  • Ozark Mountains Medical Research

    Ozark, Missouri, 65721

  • Med-Olam Clinical Research

    Pasadena, Texas, 77504

  • Southwest Clinical Research Centers, LLC

    Pearland, Texas, 77584

  • Advanced Clinical Research

    Pell City, Alabama, 35128

  • Pines Research, LLC

    Pembroke Pines, Florida, 33028

  • NISUS Research Northern MI Hospital

    Petoskey, Michigan, 49770-2212

  • Hope Clinical Research

    Phoenix, Arizona, 85006

  • Anasazi Internal Medicine

    Phoenix, Arizona, 85032

  • Tatum Ridge Internal Medicine

    Phoenix, Arizona, 85032

  • Mississippi Medical Research, LLC

    Picayune, Mississippi, 39466

  • Spence Medical Research Center, LLC

    Pinckney, Michigan, 39466

  • Paul W. Davis, MD

    Pine Bluff, Arkansas, 71603

  • Health Science Research Center

    Pratt, Kansas, 67124

  • Private Practice

    Raleigh, North Carolina, 27610

  • Perimeter North Medical Research

    Roswell, Georgia, 30076

  • Crescent Medical Research

    Salisbury, North Carolina, 28144

  • Utah Clinical Trials

    Salt Lake City, Utah, 84107

  • Diabetes & Glandular Disease Clinic , PA

    San Antonio, Texas, 78237

  • California Research Foundation

    San Diego, California, 92103

  • Ritchken and First MDs

    San Diego, California, 92117-4961

  • San Diego Sports Medicine Research and Family Care

    San Diego, California, 92120

  • Crest Clinical Trials

    Santa Ana, California, 92701

  • NuLife Clinical Research, Inc.

    Santa Ana, California, 92805

  • Westside Arthritis and Metabolism Center

    Santa Monica, California, 90404

  • Maine Centers for Endocrinology & Diabetes

    Scarborough, Maine, 04074

  • Summit Reserach Network, LLC

    Seattle, Washington, 98104

  • Jones Family Practice, PA

    Shelby, North Carolina, 28150

  • The Family Doctors

    Shreveport, Louisiana, 71115

  • Diabetes Research Center

    South Burlington, Vermont, 05403

  • Well Pharma Medical Research

    South Miami, Florida, 33143

  • Ozark Medical-Surgical Associates, Ltd.

    Springfield, Missouri, 65804

  • ClinVest Research

    Springfield, Missouri, 65807

  • The Lipid Center

    Statesville, North Carolina, 28677

  • Southwestern Medical Clinic, PC

    Stevensville, Michigan, 49127

  • Dorchester Medical Associates

    Summerville, South Carolina, 29485

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

  • Southeastern Research Associates, Inc.

    Taylors, South Carolina, 28687

  • Shore Health Group

    Toms River, New Jersey, 08753

  • Physicians Research Center

    Toms River, New Jersey, 08755

  • Cotton O'neil Clinic

    Topeka, Kansas, 66606

  • Paradigm Clinical

    Tucson, Arizona, 85705

  • Tucson Clinical Research

    Tucson, Arizona, 85712

  • Community Research Partners, Inc.

    Varnville, South Carolina, 29944

  • Patient's First Health Care

    Washington, Missouri, 63090

  • Holston Medical Group

    Weber City, Virginia, 24920

  • Center for Clinical Trials of San Gabriel

    West Covina, California, 91790

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67205

  • Pharmacotherapy Research Associates, INC

    Zanesville, Ohio, 43071

Other trials in United States

Slovakia7 sites

  • Diabetologicka ambulancia

    Komarnanska, Velky Meder, 932 01

  • Zeleznicne zdravotnictvo s.r.o., Diabetologicka ambulancia

    Košice, 040 01

  • Diabetologicka ambulancia

    Nové Mesto nad Váhom, 915 01

  • Diabetologicka ambulancia

    Prešov

  • Diabetologicka ambulancia

    Šahy, 936 01

  • Mestska poliklinika Sered, Diabetologicka ambulancia

    Sereď, 926 01

  • Diabetologicka ambulancia

    Trebišov, 075 01

Other trials in Slovakia

Canada6 sites

  • LMC Endocrinology Centres (Barrie) Ltd.

    Barrie, Ontario, L4M 7G1

  • T.C. Health Center

    Carbonear, Newfoundland and Labrador, A1Y 1C4

  • LMC Endocrinology Centres -(Etobicoke) Ltd. ,

    Etobicoke, Ontario, M9R 4E1

  • G.A. Research Associates Moncton, New Brunswick E1G 1 A7

    Moncton, New Brunswick, E1G 1 A7

  • LMC Endocrinology Centres -(Thornhill)

    Thornhill, Ontario, L4J 8L7

  • LMC Endocrinology Centres (Toronto) Ltd.

    Toronto, Ontario, M4R 2G4

Other trials in Canada

India6 sites

  • Manipal Hospital

    Bangalore, 560 017

  • MV Hospital for Diabetes and Diabetes Research Centre

    Chennai, 600 013

  • Madras Diabetes Research Foundation

    Gopālapuram, Chennai, 600 086

  • Medicity Hospital

    Hyderabaad, Hyderabad, 500 036

  • Diabetes Thyroid Hormone Research Institute Pvt Ltd.

    Indore, 452 001

  • Christian Medical College

    Vellore, 632 004

Other trials in India

Puerto Rico5 sites

  • Policlinica Dr. Luis Rodriguez Carrasquillo

    Carolina, 00983

  • Yolanda Sierra Medical Office

    Levittown, 00949

  • Endocrine Lipid Diabetes Research Institute

    Ponce, 00717-1471

  • Centro Clinico San Patricio

    San Juan, 00921

  • Miguel Sosa-Padilla, M.D.

    San Juan, 00926

Other trials in Puerto Rico

Romania5 sites

  • CMI Cardiologie

    Baia Mare

  • Paulescu Institute

    Bucharest

  • Anamed SRL

    Oradea

  • Emergency County Hospital Ploiesti

    Ploieşti

  • Policlinica

    Timișoara

Other trials in Romania

Malaysia3 sites

  • Hospital University Kebangsaan Malaysia

    Kuala Lumpur, Selangor

  • University Malaya Medical Centre

    Selangor Darul Ehsan, Ehsan

  • Hospital Putrajaya

    Selangor Darul Ehsan, Selangor

Other trials in Malaysia

Philippines3 sites

  • Metropolitan Medical Center

    Manila

  • Institute for Studies on Diabetes Foundation

    Marikina City

  • Jose R. Reyes Memorial Medical Center

    Sta Cruz, Manila

Other trials in Philippines

About this study

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.

Being tested
Vildagliptin, Placebo
Keywords
Type 2 Diabetes, Vildagliptin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VildagliptinDrug

  • VildagliptinDrug

  • PlaceboDrug

Study groups in NCT00821977
Study groupRoleWhat they receive
Vildagliptin Dose 1ExperimentalNot described
Receives: Drug: Vildagliptin
Vildagliptin Dose 2ExperimentalNot described
Receives: Drug: Vildagliptin
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM by assessing changes in HbA1c from baseline to 24 weeks.

    Measured: 24 weeks

Secondary outcomes (4)

  1. Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM as measured by changes in fasting plasma glucose from baseline to 24 weeks

    Measured: 24 weeks

  2. Measure: To evaluate the safety and tolerability of vildagliptin compared to placebo over 24 weeks of treatment as monotherapy in patients with T2DM

    Measured: 24 weeks

  3. Measure: To evaluate the long-term safety and tolerability of vildagliptin over the entire study duration as monotherapy in patients with T2DM

    Measured: 76 weeks

  4. Measure: To evaluate the body weight change from baseline with vildagliptin compared to placebo after 24 weeks of treatment as monotherapy in patients with T2DM

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2009 (estimated)
  2. Study startNov 2008
  3. Primary completionOct 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
338 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00821977
Sponsor's protocol ID
CLAF237B2201
Status last verified
May 2012
First submitted
13 Jan 2009
Last updated
17 Dec 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Vildagliptin in people with Diabetes Mellitus, Type 2, run by Novartis at 176 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in United States, Slovakia, Canada, India, Puerto Rico and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM by assessing changes in HbA1c from baseline to 24 weeks. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00821977.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.

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